In February 2012, a dozen members of the Food and Drug Administration’s Neurological Device Panel spent a Friday on the stage of a Hilton ballroom hearing about cranial electrotherapy stimulation (CES) devices. Tracey Kirsch was in the audience while the panel was warned by FDA personnel no fewer than 25 times that CES—a weak, pulsed electrical current delivered across the head—causes seizures. Kirsch runs a company that produces AlphaStim, one such device that attaches to the ear lobes and may treat anxiety, depression, and insomnia by briefly inhibiting activity in the brain’s cortex.
The hearing in Washington would determine whether CES devices would be reclassified from a Class III device (meant for life-sustaining products like heart valves) to a Class II device (alongside powered wheelchairs and pregnancy tests). Having used her allotted 45 minutes in the morning to argue for reclassification, Kirsch could not rise to object that not a single seizure had been caused in the 30-year marketing history of the product. Despite their largest customer being Veteran’s Affairs, many of whose patients are routinely offered CES treatment in VA facilities, there seems to be a mistrust of the technology at the FDA, expressed through sometimes-arbitrary criteria that discard the majority of supporting evidence. Eventually a witness clarified that the one documented seizure had happened during a clinical trial’s five-day drug washout period, before the electrotherapy had even begun. Unlike CES, benzodiazepine withdrawal frequently causes seizures.